Dexmedetomidine Infusion in Hypospadias Surgery

An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926705

Enrollment

Registered

2009-06-23

Start date

2008-06-30

Completion date

2009-01-31

Last updated

2009-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Dexmedetomidine, Fentanyl, Pain, Pediatrics

Brief summary

The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.

Interventions

DRUGDexmedetomidine and Fentanyl

Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.

DRUGFentanyl

This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

MALE

Age

1 Years to 12 Years

Healthy volunteers

Inclusion criteria

* Children aged 1-12 years undergoing hypospadias repair

Exclusion criteria

* Allergy to Dexmedetomidine * Preoperative use of sedatives or analgesics * cardiac diseases * Children with mental retardation

Design outcomes

Primary

Measure	Time frame
Intraoperative and postoperative fentanyl requirement (in microg/kg)	6/2008-1/2009

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026